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NCT05926765 | RECRUITING | Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands

A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Sponsor:

MeiraGTx, LLC

Brief Summary:

This study will assess the efficacy and safety of bilateral intra-parotid administration of AAV2-hAQP1 in adults with Grade 2 or Grade 3 radiation-induced late xerostomia.

Condition or disease

Grade 2 and 3 Late Xerostomia Caused by Radiotherapy for Cancers of the Upper Aerodigestive Tract, Excluding the Parotid Glands

Intervention/treatment

AAV2-hAQP1 Concentration 1

AAV2-hAQP1 Concentration 2

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia
Actual Study Start Date : 2023-06-13
Estimated Primary Completion Date : 2025-07
Estimated Study Completion Date : 2025-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit
  • * No history of parotid gland cancer, recurrent cancer, or a second primary cancer
  • * An unstimulated whole saliva flow rate (mL/min) \>0 (i.e., at least one drop of saliva in the collection tube)
  • * A stimulated whole saliva flow rate (mL/min) within a specified range after mechanical stimulation by chewing
  • * Average screening XQ Total Score at or above a specified threshold
  • * No evidence of head and neck cancer, defined as a negative otolaryngology exam and a negative computed tomography (CT) scan of the head, neck, and chest with contrast. If a participant has had a magnetic resonance imaging (MRI) study, CT scan, positron emission tomography (PET), or fluorodeoxyglucose-positron emission tomography (FDG-PET) scan of the head, neck, and chest within 6 months of study entry (and at least 3 years after the completion of radiotherapy), then that image may be used for eligibility determination and a CT scan at screening will not be required.
  • * Either received treatment with one or more prescription sialagogues and elected to discontinue therapy or, in consultation with their physician, elected to not initiate such treatment
  • * Participants taking a prescription sialagogue (specifically, pilocarpine or cevimeline) must stop that medication at least 2 weeks prior to Screening and be willing to refrain from taking such medications for the duration of the study
  • * Participants who require medication for an underlying medical condition that is known to affect salivary output must be on stable doses of such medications for at least one month prior to the first screening visit
Exclusion Criteria
  • * Any malignancy within the preceding 3 years, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma
  • * History of systemic autoimmune disease affecting the salivary glands (e.g., Sjogren's disease)
  • * Currently using systemic immunosuppressive medication(s) (e.g., corticosteroids or biologics) or treated with one within 4 weeks of the first screening visit. Note: Topical, inhaled, or intranasal corticosteroids are permitted.
  • * Active viral infection with Epstein-Barr virus (EBV), defined as a positive anti-VCA IgM. In the event a potential participant has a positive anti-VCA IgM, they may be rescreened 2-4 months later at which time a positive Epstein-Barr Virus Nuclear Antigen (EBNA) will be considered as evidence of resolved EBV infection.
  • * Evidence of active Hepatitis C virus (HCV) infection
  • * Evidence of human immunodeficiency virus (HIV) infection
  • * Diagnosis of myasthenia gravis
  • * Personal or family history of acute or chronic angle-closure glaucoma (ACG), or at increased risk of developing ACG, or had prophylactic treatment to reduce the risk of developing ACG
  • * Known allergy or hypersensitivity to glycopyrrolate
  • * Current smokers or history of smoking within the preceding 3 years (includes vaping with tobacco additives)
  • * Current alcohol misuse or a history of the same within the preceding 3 years (defined for men as an average intake of more than 14 drinks per week and for women as more than 7 drinks per week)
  • * Poorly controlled diabetes (hemoglobin A1c \>7%)
A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia

Location Details

NCT05926765

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States, 85234

RECRUITING

United States, California

City of Hope

Duarte, California, United States, 91010

RECRUITING

United States, Florida

Miami Cancer Institute at Baptist Health South Florida

Miami, Florida, United States, 33176

RECRUITING

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

RECRUITING

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21231

RECRUITING

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

RECRUITING

United States, Road cancer

Henry Ford Health

Detroit, Road cancer, United States, 48202

RECRUITING

United States, Missouri

University of Missouri

Columbia, Missouri, United States, 65212

RECRUITING

United States, New York

Erie County Medical Center

Buffalo, New York, United States, 14215

RECRUITING

United States, North Carolina

UNC-Chapel Hill

Chapel Hill, North Carolina, United States, 27514

RECRUITING

United States, North Carolina

Atrium Health

Charlotte, North Carolina, United States, 28203

RECRUITING

United States, Pennsylvania

Penn State

Hershey, Pennsylvania, United States, 17033

RECRUITING

United States, Pennsylvania

Alleghany General Hospital

Pittsburgh, Pennsylvania, United States, 15212

RECRUITING

United States, Texas

UT Southwestern Medical Center

Dallas, Texas, United States, 75390

RECRUITING

United States, Texas

Houston Methodist

Houston, Texas, United States, 77030

RECRUITING

Canada, Ontario

Shirley and Jim Fielding Northeast Cancer Centre - Health Sciences North

Sudbury, Ontario, Canada, P3E 5J1

RECRUITING

Canada,

Ciusss-McQ (Trois-Rivières, QC)

Trois-Rivières, Canada, Conquest

RECRUITING

United Kingdom,

Addenbrooke's Hospital

Cambridge, United Kingdom,

RECRUITING

United Kingdom,

Ninewells Hospital & Medical School

Dundee, United Kingdom, DD1 9SY

RECRUITING

United Kingdom,

Western General

London, United Kingdom, EH4 2XU

RECRUITING

United Kingdom,

Guys Hospital

London, United Kingdom, SE1 9RT

RECRUITING

United Kingdom,

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom, Ng7 2UH